Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611461

FEI Number

3002806822

Entity Name

OERTEL MEDIZINTECHNIK

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

GRANEGGWEG 20, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OERTEL MEDIZINTECHNIK (Owner Number: 8010227)

Owner / Operator Contact Address

GRANEGGWEG 20, --, TUTTLINGEN, DE-NOTA 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	1994-07-27
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-01
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1986-05-04
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1994-09-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-17
KAZ	Rasp, Frontal-Sinus	Ear, Nose, Throat	Class 1	874.4420	2013-01-31
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	1978-04-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1997-05-01
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	1986-06-13
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-06-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1986-06-13
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1997-05-01
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1997-05-01
KAT	Perforator, Antrum	Ear, Nose, Throat	Class 1	874.4420	1986-06-13
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-05-01
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1984-09-07
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-06-13
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2013-01-31
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2013-01-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-06-17

Official Correspondent

RALF OERTEL

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

OERTEL MEDIZINTECHNIK

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
3005067367	SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP.	Shanghai, CN
3015487912	SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611461. Last updated year: 2026. Please use registration number 9611461 when referencing this establishment in official correspondence.